Amlodipine
- Product NDC
- 33342-015
- 11-digit product format
- 333420015
- Labeler code
- 33342
- Product ID
- 33342-015_cf534093-9769-44f3-8570-337fad041447
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA201380
- Marketing category
- ANDA
- Marketing start
- 2012-04-13
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 33342-015 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 33342-015 | 33342-015-10 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 33342-015 | 33342-015-12 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A201380-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | | 2012-04-13 |
| A201380-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | | 2012-04-13 |
| A201380-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | | 2026-02-17 |
Therapeutic equivalence codes#
DailyMed Socrata Ingredients#